Ben Arous regional Hospital
Ben Arous, 2096, Tunisia
NCT Number: NCT07194967
The aim of this study is to evaluate the impact of virtual reality hypnosis technique on pain and anxiety of women during labor. We will perform a randomized controlled trial on a group of labouring women at several hospitals in Tunis. We will also evaluate the satisfaction of women after the exposure to the virtual reality headset.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
Ben Arous, 2096, Tunisia
This multicenter randomized controlled trial evaluates the effectiveness of a virtual reality hypnosis device (HypnoVR) in managing pain and anxiety during labor. Women in the latent and active phases of labor will be randomly assigned to either a VR intervention group or a control group receiving standard care.
Primary outcomes include pain level, measured using the Visual Analogue Scale (VAS), and anxiety level, assessed with the State-Trait Anxiety Inventory (STAI-Y). Both will be evaluated before and after the intervention.
Secondary outcomes include maternal vital signs (blood pressure and pulse), labor parameters (contraction frequency, duration, and intensity via NST), fetal parameters (heart rate and decelerations via Doppler), and maternal satisfaction (measured postpartum using a VAS satisfaction scale).
This study aims to determine whether HypnoVR can be an effective non-pharmacological method for improving the labor experience.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria to be eligible for inclusion in the study:
Exclusion criteria
Participants will be excluded from the study if they meet any of the following criteria:
For patients randomized to the intervention arm, the investigator will provide a clear explanation of the procedure and the use of the HypnoVR virtual reality headset. The investigator will remain present throughout the session to supervise the experience, using the companion tablet to monitor the visualization in real time.
Participants will be invited to select one of eight immersive visual environments designed to promote relaxation and analgesia during labor. Available options include: Tropical Beach, Underwood, Underwater Dive, Zen Garden, Astral Travel, Winter Landscape, Aurora Borealis, and Oasis.
Patients will be informed that they may discontinue the use of the headset at any time and for any reason, without any consequences for their standard medical care.
Time frame: Immediately before starting the intervention and immediately after completing the intervention
The investigator assessed the pain level before and after the intervention using a Visual Analogue Scale VAS. The score ranges from 0 (no pain at all) to 10 (the worst pain imaginable).
Time frame: Immediately before starting the intervention and immediately after completing the intervention
The investigator assessed the Anxiety level using the State Trait Anxiety Inventory (STAI) forme Y. The score ranges from 20 to 80 and higher scores are associated with higher levels of anxiety.
Time frame: Immediately before starting the intervention and immediately after completing the intervention, both systolic and diastolic blood pressures are mesures in millimetres of mercury (mmHg)
Blood pressure in millimetres of mercury (mmHg)
Time frame: Immediately before starting the intervention and immediately after completing the intervention
pulse rate mesured in heart beat per minute (bpm)
Time frame: Immediately before starting the intervention and immediately after completing the intervention
contractions intensity is measured by NST machine, in millimiter of mercury (mmHg)
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Contraction frequency per 10 mn These measurements were made using an NST machine
Time frame: Immediately before starting the intervention and immediately after completing the intervention
contraction duration measured in minutes
Time frame: After giving birth postpartum within two hours (H2)
Satisfaction will be assessed using the Visual Analog Scale for Satisfaction (VAS; 0 = not at all satisfied, 10 = completely satisfied), with higher scores indicating greater satisfaction
University Tunis El Manar
Other
Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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